Comparison the effect of ovarian suspension and hyaluronic acid gel in prevention of ovarian re-adhesion after laparoscopic surgery for stage 3&4 endometriosis. A Randomized, Double-blind Clinical trial
This study aimed to Comparison the effect of ovarian suspension and hyaluronic acid gel in prevention of ovarian re-adhesion after laparoscopic surgery for stage 3&4 endometriosis. After confirming the inclusion criteria and obtain the written consent of the individual, randomly one of the ovaries of the group ovarian suspension and the other hyaluronic acid gel is assigned. For random allocation of ovaries in each one of random sampling and in order to hide the sealed envelopes and then use the results of an ultrasound can be used during laparoscopy. The patients in the laparoscopic surgery and after the release of adhesions, a fixed ovaries and ovarian abdomen is covered by the Endogel. The patients after surgery then will be assessed 3 month later. Sample size in study is 50 patients. The primary outcome is the occurrence of adhesions that this will be assessed by ultrasound. Secondary outcomes include the severity of adhesions, the degree and depth of ovarian inactivity is determined by ultrasound. Inclusion criteria, all patients 18 to 40 years old with chronic pelvic pain of endometriosis with grade 3 and 4, severe menstrual pain, suffering and in examinations and tests, ultrasound or MRI strong doubt has been created to endometriosis. Exclusion criteria include patients who have a tendency to review the plan or during laparoscopic bilateral ovarian adhesion is not observed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081723666N1
Registration date:2015-12-19, 1394/09/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-19, 1394/09/28
Registrant information
Name
Abolfazl Mehdizadeh kashi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 216651500
Email address
mehdizadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2016-11-01, 1395/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of ovarian suspension and hyaluronic acid gel in prevention of ovarian re-adhesion after laparoscopic surgery for stage 3&4 endometriosis. A Randomized, Double-blind Clinical trial
Public title
The effect of ovariopexy and endogel in prevention of endometriosis readhesion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 18 to 40 years old patients suspicious to stage 3 & 4 endometriosis, because of chronic pelvic pain, severe dysmenorrhea dyspareunia and infertility, positive physical examinations and related tumor markers, ultrasound or MRI, who are candidate for laparoscopic surgery and have signed a consent form.
Exclusion criteria: Patients who have not signed the consent form and have not shown bilateral ovarian adhesions at the time of laparoscopy, or have any contraindication for surgery and anesthesia.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Iran University of Medical Science
Street address
Iran . Tehran . Hemat Highway . Milad Tower
City
Tehran
Postal code
Approval date
2015-08-03, 1394/05/12
Ethics committee reference number
IR.IUMS.REC.1394
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N 80.0
ICD-10 code description
Endometriosis of uterus
Primary outcomes
1
Description
Ovarian adhesion
Timepoint
3 months after surgery
Method of measurement
To determine the adherence of patients a questionnaire developed by the researchers used ultrasound accreditation by the outcome of the results of ultrasound during laparoscopy is examined
Secondary outcomes
1
Description
pain
Timepoint
3 month after operation
Method of measurement
Visual analogue scale
Intervention groups
1
Description
Application of Hyaluronic Acid gel to to the adhesion site.
Category
Prevention
2
Description
Fixation of the ovary to abdominal wall
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul e Akram Hospital
Full name of responsible person
Abolfazal Mehdizadeh Kashi
Street address
Niayesh Av. Sattar khan St. Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Pars General Hospital
Full name of responsible person
Dr. Shahla Chaichian
Street address
No11, Saeedi Alley, Fereshteh St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Ali Javad Musavi
Street address
Research Deputy office of Iran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Abolfazl Mehdizadeh
Position
MD. Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Rasoul Akram Hospital, Niayesh Av. Sattar khan St. Tehran, Iran
City
Tehran
Postal code
1449613131
Phone
+98 21 6650 9283
Fax
Email
amehdizadehkashi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Tehran Medical Sciences Branch
Full name of responsible person
Dr. Shahla Chaichian
Position
Associate Professor Fellowship of Laparoscopic Gynecology